Trial Outcomes & Findings for Lifestyle Enriching Activities for Research in Neuroscience Intervention Trial: LEARNit Study (NCT NCT02726906)
NCT ID: NCT02726906
Last Updated: 2024-10-02
Results Overview
Functional MRI has proven to be an effective non-invasive, in-vivo tool for measuring brain function via the BOLD signal. Growing evidence supports that fMRI BOLD can detect neuronal changes that occur very early in the disease process. The hippocampus has been shown to be a selectively vulnerable region in AD, and several studies, including our own, identified a aberrant brain signal in the hippocampus in older adults. The typical range for this outcome is -10 to 10 with higher scores indicating better brain function.
COMPLETED
NA
66 participants
Baseline and Follow-up at 6 months
2024-10-02
Participant Flow
Participants complete a 30-day run-in and baseline visit prior to randomization.
Participant milestones
| Measure |
Moderate-aerobic Walking
Participants will complete a 6-month home-based moderate-aerobic walking program of 150 minutes per week with the assistance of an interventionist.
Moderate-aerobic walking
Positron Emission Tomography (PET) scan: Radioligand that binds to proteins using a PET/CT scanner.
Physical activity monitor: Wrist device that will track daily physical activity
|
Healthy Living Education
Participants will receive monthly topics on healthy living lifestyles for self-paced reading over 6 months with the assistance of an interventionist.
Positron Emission Tomography (PET) scan: Radioligand that binds to proteins using a PET/CT scanner.
Healthy living education
Physical activity monitor: Wrist device that will track daily physical activity
|
|---|---|---|
|
Overall Study
STARTED
|
33
|
33
|
|
Overall Study
COMPLETED
|
30
|
30
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Lifestyle Enriching Activities for Research in Neuroscience Intervention Trial: LEARNit Study
Baseline characteristics by cohort
| Measure |
Moderate-aerobic Walking
n=33 Participants
Participants will complete a 6-month home-based moderate-aerobic walking program of 150 minutes per week with the assistance of an interventionist.
Moderate-aerobic walking
Positron Emission Tomography (PET) scan: Radioligand that binds to proteins using a PET/CT scanner.
Physical activity monitor: Wrist device that will track daily physical activity
|
Healthy Living Education
n=33 Participants
Participants will receive monthly topics on healthy living lifestyles for self-paced reading over 6 months with the assistance of an interventionist.
Positron Emission Tomography (PET) scan: Radioligand that binds to proteins using a PET/CT scanner.
Healthy living education
Physical activity monitor: Wrist device that will track daily physical activity
|
Total
n=66 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.4 years
STANDARD_DEVIATION 7.1 • n=5 Participants
|
67.3 years
STANDARD_DEVIATION 6.4 • n=7 Participants
|
67.3 years
STANDARD_DEVIATION 6.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
26 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
33 participants
n=5 Participants
|
33 participants
n=7 Participants
|
66 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Follow-up at 6 monthsPopulation: Definition of ITT analysis sample: all eligible participants who (1) began the intervention and (2) completed baseline assessment and 6-month assessment for the primary analysis of fMRI BOLD and MST behavioral test. All consented, randomized participants are grouped according to the treatment assigned at randomization. MRI data was not available for one participant in the Healthy Living Education group, resulting in an N of 29 for all fMRI measures.
Functional MRI has proven to be an effective non-invasive, in-vivo tool for measuring brain function via the BOLD signal. Growing evidence supports that fMRI BOLD can detect neuronal changes that occur very early in the disease process. The hippocampus has been shown to be a selectively vulnerable region in AD, and several studies, including our own, identified a aberrant brain signal in the hippocampus in older adults. The typical range for this outcome is -10 to 10 with higher scores indicating better brain function.
Outcome measures
| Measure |
Moderate-aerobic Walking
n=30 Participants
Participants will complete a 6-month home-based moderate-aerobic walking program of 150 minutes per week with the assistance of an interventionist.
Moderate-aerobic walking
Positron Emission Tomography (PET) scan: Radioligand that binds to proteins using a PET/CT scanner.
Physical activity monitor: Wrist device that will track daily physical activity
|
Healthy Living Education
n=29 Participants
Participants will receive monthly topics on healthy living lifestyles for self-paced reading over 6 months with the assistance of an interventionist.
Positron Emission Tomography (PET) scan: Radioligand that binds to proteins using a PET/CT scanner.
Healthy living education
Physical activity monitor: Wrist device that will track daily physical activity
|
|---|---|---|
|
Functional Magnetic Resonance Imaging (fMRI) Brain Scan as a Measure of Brain Function
Follow-up
|
0.018 units on a scale
Interval -0.274 to 0.31
|
0.033 units on a scale
Interval -0.267 to 0.333
|
|
Functional Magnetic Resonance Imaging (fMRI) Brain Scan as a Measure of Brain Function
Baseline
|
-0.442 units on a scale
Interval -0.879 to -0.005
|
-0.203 units on a scale
Interval -0.65 to 0.243
|
PRIMARY outcome
Timeframe: Baseline and Follow-up at 6 monthsPopulation: Definition of ITT analysis sample: all eligible participants who (1) began the intervention and (2) completed baseline assessment and 6-month assessment for the primary analysis of fMRI BOLD and MST behavioral test. All consented, randomized participants are grouped according to the treatment assigned at randomization.
The participants will encode a series of objects presented on a computer. Following the encoding period, they will begin their fMRI scan and be asked to indicate if they recognize the objects on the screen, which include targets (previously seen objects), lures (objects that are similar to previously seen objects) and novel (unrelated objects). The discrimination between Targets and Lures will indicate the rate at which participants "correctly reject" the Lures (via pattern separation) or "false alarm" to the Lures (via pattern completion). The theoretical range for this outcome is -1 to 1 with higher scores indicating better memory function.
Outcome measures
| Measure |
Moderate-aerobic Walking
n=30 Participants
Participants will complete a 6-month home-based moderate-aerobic walking program of 150 minutes per week with the assistance of an interventionist.
Moderate-aerobic walking
Positron Emission Tomography (PET) scan: Radioligand that binds to proteins using a PET/CT scanner.
Physical activity monitor: Wrist device that will track daily physical activity
|
Healthy Living Education
n=30 Participants
Participants will receive monthly topics on healthy living lifestyles for self-paced reading over 6 months with the assistance of an interventionist.
Positron Emission Tomography (PET) scan: Radioligand that binds to proteins using a PET/CT scanner.
Healthy living education
Physical activity monitor: Wrist device that will track daily physical activity
|
|---|---|---|
|
Mnemonic Similarity Test as a Measure of Memory (Cognition)
Follow-up
|
0.28 score on a scale
Interval 0.18 to 0.37
|
0.36 score on a scale
Interval 0.27 to 0.45
|
|
Mnemonic Similarity Test as a Measure of Memory (Cognition)
Baseline
|
0.32 score on a scale
Interval 0.23 to 0.41
|
0.32 score on a scale
Interval 0.23 to 0.41
|
SECONDARY outcome
Timeframe: Baseline and Follow-up at 6 monthsPopulation: Definition of ITT analysis sample: all eligible participants who (1) began the intervention and (2) completed baseline assessment and 6-month assessment for the primary analysis of fMRI BOLD and MST behavioral test. All consented, randomized participants are grouped according to the treatment assigned at randomization.
Each participant received PET scans with Neuraceq \[florbetaben F 18 (FBB)\] to measure amyloid-beta PET binding. IV injections of the tracers (FBB, -8.11 6 0.6 mCi) were done outside of the scanning room. Four 5-min frames were acquired 90 minutes after injection.
Outcome measures
| Measure |
Moderate-aerobic Walking
n=30 Participants
Participants will complete a 6-month home-based moderate-aerobic walking program of 150 minutes per week with the assistance of an interventionist.
Moderate-aerobic walking
Positron Emission Tomography (PET) scan: Radioligand that binds to proteins using a PET/CT scanner.
Physical activity monitor: Wrist device that will track daily physical activity
|
Healthy Living Education
n=30 Participants
Participants will receive monthly topics on healthy living lifestyles for self-paced reading over 6 months with the assistance of an interventionist.
Positron Emission Tomography (PET) scan: Radioligand that binds to proteins using a PET/CT scanner.
Healthy living education
Physical activity monitor: Wrist device that will track daily physical activity
|
|---|---|---|
|
Amyloid Positron Emission Tomography (PET) Scan as a Measure of Tracer Binding (SUVr)
Baseline
|
1.05 standardized uptake value ratio (SUVr)
Interval 0.99 to 1.11
|
1.01 standardized uptake value ratio (SUVr)
Interval 0.94 to 1.07
|
|
Amyloid Positron Emission Tomography (PET) Scan as a Measure of Tracer Binding (SUVr)
Follow-up
|
1.05 standardized uptake value ratio (SUVr)
Interval 0.99 to 1.12
|
1.01 standardized uptake value ratio (SUVr)
Interval 0.94 to 1.08
|
SECONDARY outcome
Timeframe: Baseline and Follow-up at 6 monthsPopulation: Definition of ITT analysis sample: all eligible participants who (1) began the intervention and (2) completed baseline assessment and 6-month assessment for the primary analysis of fMRI BOLD and MST behavioral test. All consented, randomized participants are grouped according to the treatment assigned at randomization.
This is a measure of cardiovascular fitness. This test has been validated against peak VO2 max with r=0.96. Heart rate response is monitored with a Polar heart rate monitor and the heart rate at the end of the 4 min test is used to estimate VO2max using an established equation for conversion. The theoretical range for this outcome is 0 to 200 with higher scores indicating better cardiovascular fitness.
Outcome measures
| Measure |
Moderate-aerobic Walking
n=30 Participants
Participants will complete a 6-month home-based moderate-aerobic walking program of 150 minutes per week with the assistance of an interventionist.
Moderate-aerobic walking
Positron Emission Tomography (PET) scan: Radioligand that binds to proteins using a PET/CT scanner.
Physical activity monitor: Wrist device that will track daily physical activity
|
Healthy Living Education
n=30 Participants
Participants will receive monthly topics on healthy living lifestyles for self-paced reading over 6 months with the assistance of an interventionist.
Positron Emission Tomography (PET) scan: Radioligand that binds to proteins using a PET/CT scanner.
Healthy living education
Physical activity monitor: Wrist device that will track daily physical activity
|
|---|---|---|
|
Single-stage Treadmill Test
Baseline
|
29.5 units on a scale
Interval 27.4 to 31.6
|
30.0 units on a scale
Interval 27.8 to 32.1
|
|
Single-stage Treadmill Test
Follow-up
|
31.2 units on a scale
Interval 29.2 to 33.3
|
31.1 units on a scale
Interval 29.0 to 33.2
|
SECONDARY outcome
Timeframe: Baseline and Follow-up at 6 monthsPopulation: Definition of ITT analysis sample: all eligible participants who (1) began the intervention and (2) completed baseline assessment and 6-month assessment for the primary analysis of fMRI BOLD and MST behavioral test. All consented, randomized participants are grouped according to the treatment assigned at randomization.
This test is a measure of multiple domains related to functional activities of daily living. Each physical activity in score is of varying difficulty level. The theoretical range for this outcome is 0 to 36 with higher scores indicating better physical function.
Outcome measures
| Measure |
Moderate-aerobic Walking
n=30 Participants
Participants will complete a 6-month home-based moderate-aerobic walking program of 150 minutes per week with the assistance of an interventionist.
Moderate-aerobic walking
Positron Emission Tomography (PET) scan: Radioligand that binds to proteins using a PET/CT scanner.
Physical activity monitor: Wrist device that will track daily physical activity
|
Healthy Living Education
n=30 Participants
Participants will receive monthly topics on healthy living lifestyles for self-paced reading over 6 months with the assistance of an interventionist.
Positron Emission Tomography (PET) scan: Radioligand that binds to proteins using a PET/CT scanner.
Healthy living education
Physical activity monitor: Wrist device that will track daily physical activity
|
|---|---|---|
|
Modified Physical Function Test
Baseline
|
33.1 score on a scale
Interval 32.2 to 33.9
|
33.0 score on a scale
Interval 32.1 to 33.9
|
|
Modified Physical Function Test
Follow-up
|
33.6 score on a scale
Interval 32.7 to 34.4
|
33.7 score on a scale
Interval 32.8 to 34.6
|
SECONDARY outcome
Timeframe: Baseline and Follow-up at 6 monthsPopulation: Definition of ITT analysis sample: all eligible participants who (1) began the intervention and (2) completed baseline assessment and 6-month assessment for the primary analysis of fMRI BOLD and MST behavioral test. All consented, randomized participants are grouped according to the treatment assigned at randomization. BDNF Plasma sample for one participant in the Healthy Living Education group did not pass QC thresholds and was excluded from analyses.
We will quantitatively analyze pre- and post-measurements of brain derived neurotrophic factor (BDNF). BDNF has been shown to increase after exercise intervention in humans and peripheral increases in these hormones correlate to cell proliferation in the dentate gyrus of the hippocampus. We measure total BDNF from plasma.
Outcome measures
| Measure |
Moderate-aerobic Walking
n=30 Participants
Participants will complete a 6-month home-based moderate-aerobic walking program of 150 minutes per week with the assistance of an interventionist.
Moderate-aerobic walking
Positron Emission Tomography (PET) scan: Radioligand that binds to proteins using a PET/CT scanner.
Physical activity monitor: Wrist device that will track daily physical activity
|
Healthy Living Education
n=29 Participants
Participants will receive monthly topics on healthy living lifestyles for self-paced reading over 6 months with the assistance of an interventionist.
Positron Emission Tomography (PET) scan: Radioligand that binds to proteins using a PET/CT scanner.
Healthy living education
Physical activity monitor: Wrist device that will track daily physical activity
|
|---|---|---|
|
Brain-derived Neurotropic Factor (BDNF) as a Measure From Blood
Baseline
|
5.80 pg/mL
Interval 3.13 to 8.46
|
8.11 pg/mL
Interval 5.39 to 10.83
|
|
Brain-derived Neurotropic Factor (BDNF) as a Measure From Blood
Follow-up
|
6.15 pg/mL
Interval 3.5 to 8.8
|
6.63 pg/mL
Interval 3.87 to 9.39
|
Adverse Events
Moderate-aerobic Walking
Healthy Living Education
Serious adverse events
| Measure |
Moderate-aerobic Walking
n=30 participants at risk
Participants will complete a 6-month home-based moderate-aerobic walking program of 150 minutes per week with the assistance of an interventionist.
Moderate-aerobic walking
Positron Emission Tomography (PET) scan: Radioligand that binds to proteins using a PET/CT scanner.
Physical activity monitor: Wrist device that will track daily physical activity
|
Healthy Living Education
n=30 participants at risk
Participants will receive monthly topics on healthy living lifestyles for self-paced reading over 6 months with the assistance of an interventionist.
Positron Emission Tomography (PET) scan: Radioligand that binds to proteins using a PET/CT scanner.
Healthy living education
Physical activity monitor: Wrist device that will track daily physical activity
|
|---|---|---|
|
Cardiac disorders
Cardiac disorders
|
3.3%
1/30 • Time between baseline and followup visit of 6-8 month intervention.
|
0.00%
0/30 • Time between baseline and followup visit of 6-8 month intervention.
|
Other adverse events
| Measure |
Moderate-aerobic Walking
n=30 participants at risk
Participants will complete a 6-month home-based moderate-aerobic walking program of 150 minutes per week with the assistance of an interventionist.
Moderate-aerobic walking
Positron Emission Tomography (PET) scan: Radioligand that binds to proteins using a PET/CT scanner.
Physical activity monitor: Wrist device that will track daily physical activity
|
Healthy Living Education
n=30 participants at risk
Participants will receive monthly topics on healthy living lifestyles for self-paced reading over 6 months with the assistance of an interventionist.
Positron Emission Tomography (PET) scan: Radioligand that binds to proteins using a PET/CT scanner.
Healthy living education
Physical activity monitor: Wrist device that will track daily physical activity
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Skin
|
26.7%
8/30 • Time between baseline and followup visit of 6-8 month intervention.
|
20.0%
6/30 • Time between baseline and followup visit of 6-8 month intervention.
|
|
Blood and lymphatic system disorders
Non-Hodgkins lymphoma
|
3.3%
1/30 • Time between baseline and followup visit of 6-8 month intervention.
|
0.00%
0/30 • Time between baseline and followup visit of 6-8 month intervention.
|
|
Musculoskeletal and connective tissue disorders
Falls
|
6.7%
2/30 • Time between baseline and followup visit of 6-8 month intervention.
|
0.00%
0/30 • Time between baseline and followup visit of 6-8 month intervention.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place